U.S. patent application number 16/761341 was filed with the patent office on 2021-03-18 for injection device with a preselector.
The applicant listed for this patent is Sanofi-Aventis Deutschland GMBH. Invention is credited to Michael Helmer, Steffen Raab, Maurice Toporek.
Application Number | 20210077741 16/761341 |
Document ID | / |
Family ID | 1000005273607 |
Filed Date | 2021-03-18 |
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United States Patent
Application |
20210077741 |
Kind Code |
A1 |
Helmer; Michael ; et
al. |
March 18, 2021 |
Injection Device with a Preselector
Abstract
An injection device for setting and injecting a dose of a
medicament comprises a housing) extending along an axial direction
(z), a dose setting mechanism arranged in the housing, a dose dial
displaceable relative to the housing for setting of the dose, a
dose tracker (50; 150) operably connectable to the dose dial (12),
the dose tracker is at least one of translationally or rotationally
displaceable relative to the housing during setting of a dose,
wherein a positional state of the dose tracker relative to the
housing is indicative of a size of the dose, and a preselector
configured to define a maximum dose positional state of the dose
tracker relative to the housing, and a first marker provided on one
of the dose tracker and the preselector and configured to indicate
the positional state of the dose tracker relative to the
preselector.
Inventors: |
Helmer; Michael; (Frankfurt
am Main, DE) ; Raab; Steffen; (Frankfurt am Main,
DE) ; Toporek; Maurice; (Frankfurt am Main,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sanofi-Aventis Deutschland GMBH |
Frankfurt am Main |
|
DE |
|
|
Family ID: |
1000005273607 |
Appl. No.: |
16/761341 |
Filed: |
November 5, 2018 |
PCT Filed: |
November 5, 2018 |
PCT NO: |
PCT/EP2018/080081 |
371 Date: |
May 4, 2020 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/585 20130101;
A61M 5/31566 20130101; A61M 5/3129 20130101; A61M 5/3155 20130101;
A61M 2205/502 20130101; A61M 2005/3154 20130101; A61M 5/28
20130101; A61M 2205/3553 20130101; A61M 2005/3126 20130101 |
International
Class: |
A61M 5/315 20060101
A61M005/315; A61M 5/28 20060101 A61M005/28; A61M 5/31 20060101
A61M005/31 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 7, 2017 |
EP |
17200317.0 |
Claims
1. An injection device for setting and injecting a dose of a
medicament, the injection device comprising: a housing; a dose
setting mechanism arranged in the housing; a dose dial displaceable
relative to the housing for setting of the dose; a dose tracker
operably connectable to the dose dial, wherein the dose tracker is
at least one of translationally displaceable or rotationally
displaceable relative to the housing during setting of a dose, and
wherein a positional state of the dose tracker relative to the
housing is indicative of a size of the dose; a preselector
configured to define a maximum dose positional state of the dose
tracker relative to the housing; and a first marker provided on one
of the dose tracker and the preselector and configured to indicate
the positional state of the dose tracker relative to the
preselector.
2. The injection device according to claim 1, wherein the
preselector is configured to vary the maximum dose positional state
of the dose tracker.
3. The injection device according to claim 1, wherein the
preselector is at least one of translationally displaceable or
rotationally displaceable relative to the housing between at least
two preselection positional states, and wherein the preselector is
lockable relative to the housing in any of the at least two
preselection positional states.
4. The injection device according to claim 1, further comprising an
indicator assembly configured to indicate when the dose tracker
reaches the maximum dose positional state.
5. The injection device according to claim 4, wherein the first
marker is located on the dose tracker, and wherein the indicator
assembly is configured to reveal the first marker on the dose
tracker when the dose tracker reaches the maximum dose positional
state.
6. The injection device according to claim 4, wherein the indicator
assembly is integrated into the preselector and comprises an
aperture extending through the preselector, and wherein the first
marker of the dose tracker is discernible through the aperture when
the dose tracker reaches the maximum dose positional state.
7. The injection device according to claim 6, wherein the indicator
assembly comprises a magnifying lens arranged in the aperture.
8. The injection device according to claim 1, wherein the dose
tracker comprises at least one tracking stop feature, wherein the
preselector comprises at least one preselector stop feature, and
wherein the preselector stop feature is configured to engage with
the at least one tracking stop feature to block and to prevent a
displacement of the dose tracker beyond the maximum dose positional
state.
9. The injection device according to claim 4, wherein the first
marker is provided on the dose tracker, wherein a second marker is
provided on the preselector, and wherein the indicator assembly is
configured to determine the positional state of the dose tracker
based on the first marker and to determine a preselection
positional state of the preselector based on the second marker.
10. The injection device according to claim 9, wherein the
indicator assembly is configured to compare the positional state of
the dose tracker with the preselection positional state of the
preselector.
11. The injection device according to claim 3, wherein the
indicator assembly comprises a processor and an electronic display
to: visualize at least one of the positional state of the dose
tracker and a preselection positional state of the preselector;
and/or visualize the positional state of the dose tracker relative
to the preselection positional state of the preselector.
12. The injection device according to claim 11, wherein the
indicator assembly comprises a communication unit connected to the
processor to exchange electronic data with a remote electronic
device.
13. The injection device according to claim 1, further comprising a
piston rod and a cartridge comprising a barrel filled with a
medicament.
14. An add-on device configured for attachment or coupling to an
injection device for setting and injecting a dose of a medicament,
the injection device comprising: a housing, a dose setting
mechanism arranged in the housing, a dose dial displaceable
relative to the housing for setting of the dose, a dose tracker
operably connectable to the dose dial, wherein the dose tracker is
at least one of translationally displaceable or rotationally
displaceable relative to the housing during setting of a dose, and
wherein a positional state of the dose tracker relative to the
housing is indicative of a size of the dose, a preselector
configured to define a maximum dose positional state of the dose
tracker relative to the housing, and a first marker provided on one
of the dose tracker and the preselector and configured to indicate
the positional state of the dose tracker relative to the
preselector; wherein the add-on device comprises: a remote
indicator assembly configured to indicate a positional state of the
dose tracker relative to the preselector.
15. The add-on device according to claim 14, wherein the remote
indicator assembly comprises at least one of: a first position
sensor configured to determine the positional state of the dose
tracker, and a second position sensor configured to determine a
preselection positional state of the preselector.
16. The add-on device according to claim 14, wherein the indicator
assembly comprises a processor and an electronic display configured
for: visualizing at least one of the positional state of the dose
tracker and a preselection positional state of the preselector;
and/or visualizing the positional state of the dose tracker
relative to the preselection positional state of the
preselector.
17. The injection device according to claim 13, wherein the barrel
is sealed by a bung that is axially displaceable relative to the
barrel by the piston rod.
18. The add-on device according to claim 14, wherein the injection
device further a cartridge comprising a barrel filled with a
medicament.
19. The add-on device according to claim 18, wherein the injection
device further comprises a piston rod and wherein the barrel of the
cartridge is sealed by a bung that is axially displaceable relative
to the barrel by the piston rod.
20. The add-on device according to claim 14, wherein the
preselector of the injection device is configured to vary the
maximum dose positional state of the dose tracker.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is the national stage entry of
International Patent Application No. PCT/EP2018/080081, filed on
Nov. 5, 2018, and claims priority to Application No. EP 17200317.0,
filed on Nov. 7, 2017, the disclosures of which are incorporated
herein by reference.
DESCRIPTION
[0002] The present disclosure relates in one aspect to injection
device, such as a pen-type injector for setting and dispensing of a
dose of a medicament. In particular, the disclosure relates to an
injection device comprising a preselector configured to preselect
or limit a maximum dose that can be a set and dispensed by the
injection device. In another aspect the disclosure relates to an
add-on device for use with an injection device in order to monitor
and/or to control operation of the injection device
BACKGROUND
[0003] Injection devices for setting and dispensing a single or
multiple doses of a liquid medicament are as such well-known in the
art. Generally, such devices have substantially a similar purpose
as that of an ordinary syringe.
[0004] Injection devices, in particular pen-type injectors have to
meet a number of user-specific requirements. For instance, with
patient's suffering chronic diseases, such as diabetes, the patient
may be physically infirm and may also have impaired vision.
Suitable injection devices especially intended for home medication
therefore need to be robust in construction and should be easy to
use. Furthermore, manipulation and general handling of the device
and its components should be intelligible and easy understandable.
Moreover, the dose setting as well as dose dispensing procedure
must be easy to operate and has to be unambiguous.
[0005] Typically, such devices comprise a housing including a
particular cartridge holder, adapted to receive a cartridge at
least partially filled with the medicament to be dispensed. Such
devices further comprise a drive mechanism, usually having a
displaceable piston rod which is adapted to operably engage with a
piston of the cartridge. By means of the drive mechanism and its
piston rod, the piston of the cartridge is displaceable in a distal
direction or dispensing direction and may therefore expel a
predefined amount of the medicament via a piercing assembly, which
is to be releasably coupled with a distal end section of the
housing of the injection device.
[0006] The medicament to be dispensed by the injection device is
provided and contained in a multi-dose cartridge. Such cartridges
typically comprise a vitreous barrel sealed in a distal direction
by means of a pierceable seal and being further sealed in proximal
direction by the piston. With reusable injection devices an empty
cartridge is replaceable by a new one. In contrast, injection
devices of disposable type are to be discarded when the medicament
in the cartridge has been dispensed or used-up.
[0007] For some applications it can be advantageous to limit a
maximum size of a dose that can be dispensed or expelled from the
cartridge. Then, unintended overdosing of the medicament could be
prevented.
Objects
[0008] It is therefore an object of the present disclosure to
provide an injection device with an increased patient safety and
which comprises a mechanism that prevents unintended overdosing of
a medicament. The injection device should provide a limited
capability to set and to dispense doses of different sizes. The
injection device should at least temporally provide setting and
dispensing of only one or a few differently sized doses. In
particular, the injection device should be configured to allow and
enable setting and dispensing of only a few, e.g. of two, three or
four differently sized doses of the medicament. Moreover,
indication or displaying of a size of a dose of appropriate size
should be simplified. Indicating or displaying of a size of a dose
should be unequivocal, intuitive and straightforward even for
patients suffering side effects such as impaired vision.
[0009] It is a further aim to provide an add-on device configured
for attachment to such an injection device or being configured to
be coupled to such an injection device in a data transferring or
information transferring way
SUMMARY
[0010] In one aspect there is provided an injection device for
setting and injecting a dose of a medicament. The injection device
comprises a housing as well as a dose setting mechanism which is
arranged in the housing. The injection device further comprises a
dose dial displaceable relative to the housing for setting of a
dose. The dose dial may be rotatably supported in or on the
housing. It may be rotationally supported at a proximal end section
of the housing. The dose dial is user actuatable. Hence, a user may
grip and rotate or displace the dose dial relative to the housing
for setting or selecting of a dose of variable size. The degree of
displacement of the dose dial relative to the housing is indicative
to the size of the dose.
[0011] Typically, the housing is also sized and configured to
accommodate a container filled with the liquid medicament. The
container may comprise a cartridge with a tubular shaped barrel and
sealed in proximal direction by means of a bung displaceably
arranged inside the barrel for expelling the dose of the medicament
via a distal end of the barrel. The distal end of the barrel may be
sealed by a pierceable seal, such as a septum.
[0012] The injection device and/or its dose setting mechanism
further comprises a dose tracker. The dose tracker is operably
connectable to the dose dial at least during setting of a dose. The
dose tracker is at least one of translationally or rotationally
displaceable relative to the housing during setting of a dose. A
positional state of the dose tracker, i.e. a position and/or an
orientation of the dose tracker relative to the housing is
indicative of a size of the dose actually set. Hence, in the
present context a `positional state` of a component includes a
position of the component and an angular orientation of the
component relative to another component or relative to the housing.
A positional state of the dose tracker reflects for instance at
least one or both of the geometric position as well as an angular
orientation of the dose tracker relative to the housing of the
injection device.
[0013] The injection device further comprises a preselector
configured to define a maximum dose positional state of the dose
tracker relative to the housing. The preselector is configured to
vary a maximum dose positional state of the dose tracker. The
maximum dose positional state of the dose tracker defines and
coincides with a maximum size of a dose that can be set and
dispensed with the injection device. By means of the preselector
the maximum dose positional state can be changed between at least
two states that reflect different maximum dose sizes of the
injection device. The preselector may be configured to block a
displacement of the dose tracker beyond the maximum dose positional
state. Depending on the configuration of the preselector the
maximum displacement of the dose dial and hence of the dose tracker
for setting of a dose can be varied.
[0014] The injection device further comprises at least a first
marker provided on one of the dose tracker and the preselector. The
first marker is configured to indicate the positional state of the
dose tracker relative to the preselector. During dose setting the
preselector is typically immobilized relative to the housing. Since
the positional state of the dose tracker relative to the housing is
indicative of a size of a dose the same is then also valid for the
preselector. Before setting of a dose or before conducting a dose
setting procedure the preselector is configured to define a maximum
dose positional state.
[0015] The position or configuration of the preselector is known.
Since the preselector is immobile or fixed to the housing at least
during setting of a dose by detecting a position or orientation of
the first marker on one of the dose tracker and the preselector a
positional state of the dose tracker relative to the preselector
can be determined. This relative position or orientation of the
first marker and hence of the dose tracker relative to the
preselector indicates whether the dose tracker has reached the
maximum dose positional state or whether the dose tracker has to be
displaced further relative to the housing in order to reach the
maximum dose positional state.
[0016] With at least a first marker a relative position and/or
orientation of the dose tracker relative to the preselector can be
determined. In this way a conventional display to indicate or to
visualize a momentary positional state of the dose tracker and/or
of the dose dial can be substituted by the first marker and its
ability to distinguish only between two positional states of the
dose tracker in relation to the preselector.
[0017] The preselector is configured to define one of a plurality
of generally possible maximum dose positional states of the dose
tracker. The configuration or manipulation of the preselector
defines one of a variety of maximum dose positional states. After a
definition of one maximum dose positional state on the basis of the
preselector the dose dial is user actuatable in order to displace
the dose tracker relative to the housing until it reaches the
maximum dose positional state.
[0018] Dispensing of a dose is only to be conducted when the dose
tracker is in the maximum dose positional state. It is therefore
sufficient and easily understandable for a user when an indication
is given on or with regard to the injection device that either a
maximum dose positional state has been reached or not. In case the
maximum dose positional state has not yet been reached the user is
encouraged to dial the dose dial further until the dose tracker
reaches the maximum dose positional state. Upon reaching the
maximum dose positional state the injection device is configured to
indicate the maximum dose positional state on the basis and by
means of the first marker.
[0019] The first marker provided on one of the dose tracker and the
preselector enables and provides a rather simple, intuitive and
easily understandable approach to provide an indicator assembly to
visualize a correct setting of a dose of predefined size. A
conventional display, e.g. in form of a dosage window in a sidewall
of a housing of an injection device, through which window a section
of a rotatable number sleeve is visible can be substituted. The
complexity of the injection device and of its operation can be
therefore reduced.
[0020] According to another example the preselector is at least one
of translationally or rotationally displaceable relative to the
housing between at least two preselection positional states. The
preselector is lockable relative to the housing in one of the two
preselection positional states. A first preselection positional
state may represent and define a first maximum dose positional
state. A second preselection positional state of the preselector
defines a second maximum dose positional state. The first and the
second maximum dose positional states are different.
[0021] The preselector is typically only one of translationally or
rotationally displaceable relative to the housing. It may comprise
a slider being slidably displaceable along a longitudinal axis of
the elongated housing. The elongated housing may comprise a tubular
or cylindrical shape. It may extend along an axial direction. In
the following, the terms axial and longitudinal are used as
synonyms. It is also conceivable that the preselector is
rotationally displaceable relative to the housing with the
longitudinal axis as an axis of rotation. Also, the preselector can
be displaced along a sidewall of the housing in a circumferential
or tangential direction. Hence, the preselector may comprise a
slider being either slidably displaceable relative to the housing
along the axial direction and/or along a tangential or
circumferential direction.
[0022] The preselector is displaceable along a displacement path.
The at least two preselection positional states of the preselector
are separated along the displacement path. In any of the at least
two preselection positional states the preselector is lockable or
fixable to the housing. In this way the preselector is stationary
and hence fixed to the housing during setting of a dose. After
completion of a dose dispensing procedure and if desired the
preselector may be displaced to another of the at least two
preselection positional states.
[0023] With the preselector, the operability and function of the
dose dial can be reduced. With the preselector a maximum size of a
dose that can be dialed or selected by means of the dose dial can
be predefined and hence limited to a given maximum. During setting
or selecting of a dose the dose dial can be displaced relative to
the housing to displace the preselector to the maximum dose
positional state. Since the maximum dose positional state is
defined by the preselector it cannot be overruled by the dose dial
or dose tracker.
[0024] In this way the dose setting procedure is divided into two
separate steps. In a first step and by making use of the
preselector a maximum dose positional state is defined for the
injection device. In a second step thereafter the dose dial is user
actuatable to move the dose tracker until it reaches the maximum
dose positional state. The separation of the dose setting procedure
into these two steps by means of two separate components, namely by
the preselector and the dose dial or dose tracker has the benefit
that the operability of the injection device in terms of dose
setting can be restricted to a limited number of dose sizes.
[0025] A caregiver or medical staff may use or configure the
preselector to define a maximum dose positional state for the dose
tracker. Control of the preselector may be prohibited for the end
user or patient. The preselector may be locked in one of the at
least two preselection positional states in such a way that the end
user or patient is unable to unlock and to modify the preselection
positional state of the preselector. In this way the end user or
patient is only given the possibility to set a dose by making use
of the dose dial, which according to the interaction between the
preselector and the dose tracker is only enabled and configured to
displace the dose tracker at maximum to the maximum dose positional
state. Overdosing can be thus effectively prevented.
[0026] Use of the injection device by a patient becomes safer since
the injection device is preconfigured for only one predefined dose
size. By means of the preselector the injection device originally
configured as a variable dose size injection device can be
transferred or transformed into a fixed dose injection device
preconfigured to set and to dispense numerous doses of a medicament
of a predefined size.
[0027] On demand and without the necessity to change the injection
device a dose size can be modified by reconfiguring the preselector
and/or by translationally or rotationally displacing the
preselector to a different preselection positional state.
[0028] According to another example the injection device comprises
an indicator assembly that is configured to indicate when the dose
tracker reaches the maximum dose positional state. The indicator
assembly is typically configured to visually indicate the
coincidence of a momentary state of the dose tracker with the
maximum dose positional state. However, the indicator assembly is
not limited to visual indicator assemblies. Generally, the
indicator assembly may comprise an audible or tactile indicator
that produces a sound or that starts to vibrate in response to the
dose tracker reaching the maximum dose positional state.
[0029] The indicator assembly is typically configured to indicate
the relative positional state between the preselector and the dose
tracker. If the at least first marker is provided on the dose
tracker the indicator assembly or at least a portion thereof is
provided on the preselector. In another example, wherein the at
least first marker is provided on the preselector the indicator
assembly or at least a portion thereof is provided on the dose
tracker. The indicator assembly is configured to cooperate or to
interact with the at least first marker. One of the dose tracker
and the preselector is typically provided with the at least first
marker wherein the other one of the dose tracker and the
preselector is provided with the indicator or at least a portion
thereof. In this way the indicator and that at least first marker
are configured to provide an indication representing a relative
position of the preselector relative to the dose tracker or vice
versa.
[0030] In another example the first marker is located on the dose
tracker. The indicator assembly is configured to reveal the first
marker on the dose tracker when the dose tracker reaches the
maximum dose positional state. The dose tracker may comprise a
longitudinally extending component of the dose setting mechanism.
The dose tracker may comprise a dose sleeve rotatable inside the
housing, axially displaceable inside the housing or being
threadedly engaged inside the housing. The preselector may comprise
a button, a dial or a slider displaceable between the at least two
preselection positional states.
[0031] The dose tracker and the preselector may be arranged in a
radially overlapping way on or inside the housing of the injection
device. During setting of a dose the dose tracker is typically
displaceable relative to the preselector and relative to the
housing of the injection device. Typically, the indicator assembly
is located on or is attached to one of the preselector and the
housing of the injection device. The housing, the preselector
and/or the indicator assembly may cover the first marker that may
be provided on an outside surface of the dose tracker as long as
the dose tracker has not yet reached the maximum dose positional
state. The indicator assembly, the preselector and the dose tracker
may be configured to reveal the at least first marker provided on
the dose tracker only when the dose tracker reaches the maximum
dose positional state. The indicator assembly may be provided by
the preselector and/or by the housing of the injection device.
[0032] In a further example the indicator assembly is integrated
into the preselector. The indicator assembly comprises an aperture
extending through the preselector. Here, the preselector may cover
at least a portion of the dose tracker. The preselector may also
cover at least a portion of a sidewall of the housing of the
injection device. The first marker that is provided on an outside
surface of the dose tracker is discernible and visible through the
aperture of the indicator assembly when the dose tracker reaches
the maximum dose positional state.
[0033] It is conceivable that the preselector is located in a
recess on the sidewall of the housing of the injection device such
that a plurality or a major portion of the recess in the sidewall,
which recess may be a through opening in the sidewall, is covered
by the preselector. Typically, the preselector is displaceable
relative to the housing along the displacement path. The dose
tracker may be also displaceable at least parallel or in the
direction of the elongation of the displacement path of the
preselector. In the maximum dose positional state the position of
the dose tracker relative to the preselector is always the same
irrespective on the position of the preselector relative to the
housing. In this way an aperture extending through the preselector
and revealing at least a portion on an outside surface of the dose
tracker is generally sufficient to indicate whether the dose
tracker has reached a maximum dose positional state or not.
[0034] The integration of the indicator assembly into the
preselector is of particular benefit since there is no need for any
further mechanical or electronic components to indicate whether a
maximum dose positional state of the dose tracker has been reached
or not. The preselector may therefore provide a twofold or double
function. On the one hand it is configured to define a maximum dose
positional state of the dose tracker. On the other hand the
preselector is enabled to visualize whether the dose tracker has
reached the predefined maximum dose positional state or not.
[0035] In another example the indicator assembly comprises a
magnifying lens arranged in the aperture. A magnifying or
magnification lens enables an enlarged view of the at least first
marker provided on the dose tracker when the at least first marker
shows up in the aperture of the preselector. A magnifying lens
provides a good, intuitive and easy legibility of the at least
first marker.
[0036] The at least first marker may comprise any visual symbol,
such as a character, a number or a colored area. For instance, the
at least first marker may comprise a green colored surface section
on the outside surface of the dose tracker. Other portions on the
outside surface of the dose tracker, such as a dedicated second
surface portion may comprise a different color, such as a red
color. As long as a red color shows up in the aperture of the
preselector this is an indication to a user, that the maximum dose
positional state of the preselector has not yet been reached. The
user is hence encouraged to dial the dose dial further in a dose
incrementing direction until the green colored first marker shows
up in the aperture of the preselector. This would be a clear and
unequivocal indication to the end user or patient that the maximum
dose positional state has been reached and that the injection
procedure, hence dispensing of a dose actually set may
commence.
[0037] In another embodiment the dose tracker comprises at least
one tracking stop feature wherein the preselector comprises at
least one preselector stop feature. The preselector stop feature is
configured to engage with the at least one tracking stop feature to
block and to prevent a displacement of the dose tracker beyond the
maximum dose positional state. Insofar the dose tracker and the
preselector are mechanically engageable.
[0038] The positional state of the preselector, hence the
preselection positional state of the preselector relative to the
housing provides an end stop and a barrier for the dose tracker
travelling in a dose incrementing direction. As soon as the dose
tracker mechanically engages with the preselector any further
displacement of the dose tracker relative to the housing in a dose
increasing direction is effectively blocked. Here, the preselector
behaves and acts as a limiter that is configured to limit a dose
setting displacement of the dose tracker and hence of the dose dial
in a dose incrementing direction relative to the housing.
[0039] As soon as the dose tracker reaches the maximum dose
positional state its tracking stop feature engages and hence abuts
with the preselector stop feature that is at least temporally
locked to a predefined longitudinal or axial portion of the
sidewall of the housing in accordance to the respective
preselection positional state of the preselector. The preselector
stop feature and the tracking stop feature may comprise mutually
corresponding stop faces, e.g. extending in circumferential and/or
radial direction so as to engage axially. Alternatively or
additionally the preselector stop feature and the tracking stop
feature may comprise mutually corresponding stop faces extending in
axial direction and radial direction so as to engage
circumferentially.
[0040] When configured to engage axially, the mutual engagement of
the preselector stop feature and the tracking stop feature provides
an axial stop thereby impeding and blocking a longitudinal or axial
translation of the dose tracker beyond the maximum axial dose
positional state.
[0041] When configured to engage circumferentially or tangentially,
the mutual engagement of the preselector stop feature and the
tracking stop feature provides a rotational stop, thereby impeding
and blocking a rotation of the dose tracker relative to the
preselector and hence relative to the housing beyond a predefined
maximum rotational dose positional state.
[0042] The selector stop feature and the limiter stop feature may
comprise both, longitudinally and circumferentially extending stop
faces configured to mutually engage. In this way a longitudinal as
well as a rotational displacement of the dose tracker relative to
the housing and hence relative to the preselector can be
effectively prevented in a twofold manner. This provides an even
improved stop configuration and mechanical abutment for the dose
tracker.
[0043] In another example the first marker is provided on the dose
tracker wherein a second marker is provided on the preselector. In
this example the first marker of the dose tracker is subject to a
displacement relative to the housing during a dose setting
procedure. The second marker which is provided on the preselector
is subject to a displacement relative to the housing during a
preselection procedure. During dose setting only the dose tracker
is moveable relative to the housing while the preselector is
stationary relative to the housing. The dose tracker is
displaceable relative to the housing until the first marker
overlaps, aligns or coincides with the second marker of the
preselector. Mutually overlapping, mutually aligning or mutually
coinciding first and second markers may be a direct indication to
the user or patient that the maximum dose positional state of the
preselector has been reached.
[0044] The first and the second markers may comprise mutually
corresponding symbols or signs, such as mutually corresponding
arrows or the like pointers providing a clear and unequivocal
appearance when aligning or overlapping mutually thus indicating
that the dose tracker has reached the maximum dose positional
state.
[0045] In another example the indicator assembly is configured to
determine the positional state of the dose tracker on the basis of
the first marker and wherein the indicator assembly is configured
to determine the preselection positional state of the preselector
on the basis of the second marker. For this it is not required that
the first and the second markers mutually align, overlap or
coincide. Rather, the indicator assembly is configured to
separately determine the positional state of the first marker and
to determine the positional state of the second marker. The
acquired positional states of the first and the second markers may
be further evaluated or processed by the indicator assembly in
order to determine whether the maximum dose positional state has
been reached or not.
[0046] For this the indicator assembly may comprise at least a
first position detector and a second position detector, wherein the
first position detector is configured to determine or to measure a
positional state of the first marker and wherein the second
position detector is configured to determine or to measure a
positional state of the second marker. In this way the indicator
assembly is configured to separately and independently determine a
positional state of the first marker and of the second marker and
hence of the dose tracker and the preselector, respectively.
[0047] This provides a multitude of geometric variations for the
specific implementation of the dose tracker and the preselector.
The preselector and the dose tracker do not have to be arranged in
an overlapping or partially overlapping configuration. The
preselector may be located at a totally different position on or in
the housing of the injection device compared to the position of the
dose tracker. This allows and enables a universal and variable
design of the injection device.
[0048] According to another example the indicator assembly is
configured to compare the positional state of the dose tracker with
the preselection positional state of the preselector. This
comparison is typically based on previously acquired or detected
positions of the first marker, e.g. provided on the dose tracker
and on the position or positional state of the second marker
provided on the preselector.
[0049] In particular, the indicator assembly may comprise an
electronic indicator assembly having at least a processor and a
display, preferably an electronic display. The processor may be
configured to compare the positional state of the dose tracker as
detected by way of of the first marker and on the basis of the
first position detector with the preselection positional state of
the preselector as detected by the second position detector by way
of of the second marker that is provided on the preselector.
[0050] First and second position detectors may be provided in or on
the housing of the injection device. The first position detector
may be configured to determine a positional state of the first
marker relative to the housing. Likewise, the second position
detector may be configured to determine the positional state of the
second marker relative to the housing. The positional states of the
first marker and the second marker as detected or measured by first
and second position detectors can be mutually compared in order to
extract and in order to determine a positional state of the dose
tracker relative to the preselector which is indicative of whether
the maximum dose positional state of the preselector has been
reached or not.
[0051] In another example the indicator assembly comprises a
processor and an electronic display. The processor and the
electronic display are configured to visualize at least one of the
positional state of the dose tracker and the preselection
positional state of the preselector. Additionally or alternatively,
the processor and the electronic display are configured to
visualize the positional state of the dose tracker relative to the
preselection positional state of the preselector. Since the
positional state of the preselector governs and defines the maximum
dose positional state of the dose tracker it is generally
sufficient to visualize the positional state of the dose tracker
relative to the preselection positional state of the
preselector.
[0052] As long as the dose tracker is not in the maximum dose
positional state, the indicator assembly, the processor and the
electronic display are configured to provide an indication that the
maximum dose positional state has not been reached. As soon and in
response to a detection that the dose tracker has reached a
positional state relative to the preselector that corresponds to
its maximum dose positional state the processor and the electronic
display are configured to indicate that the preselector has reached
the predefined maximum dose positional state.
[0053] Apart from that the processor and the electronic display may
also provide information regarding the preselection positional
state and the momentary positional state of the dose tracker. In
this way, additional information is provided to the user during a
dose setting procedure.
[0054] According to a further example the indicator assembly
comprises a communication unit connected to the processor to
exchange electronic data with a remote electronic device. A
communication unit is typically implemented as a wireless
communication unit. It may be based on conventional radio-frequency
wireless transmission standards, such as one of the communication
protocols: near field communication NFC, RFID or IEEE 802.11.
[0055] The communication unit enables data transmission and data
exchange with a remote electronic device. The remote electronic
device may comprise or may be provided by a smartphone or some
other portable electronic device. In this way, operation of the
indicator assembly and data acquired by the indicator assembly can
be transmitted to the remote electronic device. In addition, the
communication unit may enable and control a reconfiguration of the
preselector.
[0056] The presently described concept of the injection device is
not only limited to purely mechanically operated injection devices,
such as mechanically implemented injection pens. The preselector
and the injection device may be electromechanically implemented and
may be remote controlled by means of the communication module of
the indicator assembly.
[0057] Here, the remote electronic device may reconfigure the
preselector via the communication unit of the indicator assembly.
In this way and by means of the communication unit the
electronically or electromechanically implemented preselector can
be switched to one of the at least two preselection positional
states. This provides a further approach to hinder the patient or
end user to manipulate the preselector. The reconfiguration of the
preselector via the communication unit of the injection device may
be password protected or may be encoded. A reconfiguration or
manipulation of the electromechanically implemented preselector
requires knowledge of a respective electronic authorization or
code. Typically, the remote electronic device comprises a software
to enable communication with the communication unit in order to
reconfigure the preselector and/or the indicator assembly.
[0058] The communication unit, the processor and the indicator
assembly may be provided as integral components of the injection
device that are undetachably connected to the housing of the
injection device. In other embodiments a detachable solution is
provided, wherein the indicator assembly, the communication unit
and/or the processor is provided as a part of an add-on device
detachably connectable to the housing of the injection device.
[0059] According to a further example the injection device
comprises a piston rod and a cartridge. The cartridge comprises a
barrel which is filled with a medicament and which is sealed by a
bung or a piston. The bung or piston seals a proximal end of the
barrel. The bung or the piston is axially displaceable relative to
the barrel by means of the piston rod. The piston rod is
displaceable in distal direction, hence towards a distal dispensing
end of the injection device. An advancing and expelling motion of
the piston rod can be induced and controlled by a drive mechanism.
The drive mechanism may be configured to drive the piston rod in
distal direction in accordance to the positional state of the dose
tracker as previously set during a dose setting procedure. During
dose dispensing and while the piston rod advances in distal
direction the dose tracker returns from a maximum dose positional
state to a zero dose positional state.
[0060] The injection device may comprise a drive mechanism which is
purely mechanically implemented, wherein a driving force for
displacing the piston rod in distal direction is exclusively
provided by the operator, e.g. by a thumb or a finger of the
operator or user of the device. The injection device is not limited
to all mechanically implemented injection devices. The injection
device may comprise an electric drive or may comprise at least a
mechanical energy reservoir providing at least a portion of a
dispensing force required for displacing the piston rod in distal
direction during expelling of a dose from the cartridge.
[0061] According to another aspect an add-on device that is
configured for attachment to an injection device is provided.
Alternatively, the add-on device may be configured to be coupled to
the injection device. The add-on device may be coupled to the
injection device for exchanging electronic data. The add-on device
is particularly configured for attachment to or for data
transferring coupling with an injection device as described above.
The add-on device comprises at least a remote indicator assembly
that is configured to indicate a positional state of the dose
tracker of the injection device relative to the preselector of the
injection device. In this way, the injection device may be void of
an own indicator assembly. The remote indicator assembly of the
add-on device may provide and substitute the indicator assembly as
described above in connection with the injection device. This
applies when the add-on device is correctly attached to the housing
of the injection device or when the add-on device is correctly
coupled to the injection device, e.g. in a data transferring
way.
[0062] The add-on device is particularly configured for use with
disposable injection devices that are intended to be discarded
after the content of the cartridge has been used or expelled.
Typically the add-on device may comprise a fastener to engage with
a counter fastener of the housing of the injection device. In this
way the add-on device can be positioned at a well-defined location
on or at the housing of the injection device. The add-on device may
precisely determine a positional state of the dose tracker relative
to at least one of the preselector and the housing of the injection
device. Additionally or alternatively the add-on device and the
remote indicator assembly may determine a positional state of the
preselector relative to the dose tracker and/or relative to the
housing of the injection device. Swapping and exchanging one
injection device by another injection device only requires to
detach the add-on device from an initial injection device and to
attach the add-on device to the new injection device.
[0063] In a further example the remote indicator assembly of the
add-on device comprises at least one of a first position sensor and
a second position sensor. Here, the first position sensor is
particularly configured to determine the positional state of the
dose tracker. The second position sensor is particularly configured
to determine the preselection positional state of the preselector.
Insofar the remote indicator assembly may be configured to
separately determine and to separately measure a positional state
of the dose tracker and/or a preselection positional state of the
preselector independently from each other.
[0064] As described above with regard to the electronically
implemented indicator assembly also the remote indicator assembly
of the add-on device may be configured to compare the positional
state of the dose tracker with the preselection positional state of
the preselector. The first position sensor may be particularly
adapted to identify or to determine the position of the first
marker that is provided on the dose tracker. The second position
sensor may be likewise configured to determine or to detect a
positional state of the second marker that is provided on the
preselector.
[0065] In general, the remote indicator assembly may be identically
shaped and configured compared to the electronically implemented
indicator assembly of the injection device. Insofar any features,
benefits and advantages described above with regard to the
indicator assembly of the injection device are also valid and
disclosed for the remote indicator assembly of the add-on
device.
[0066] Accordingly and in another example of the add-on device the
remote indicator assembly comprises a processor and an electronic
display. The processor and the electronic display are configured to
visualize at least one of the positional state of the dose tracker
and the preselection positional state of the preselector.
Additionally or alternatively the processor and the electronic
display of the remote indicator assembly are configured to
visualize the positional state of the dose tracker relative to the
preselection positional state of the preselector.
[0067] The processor and the electronic display may be configured
to visualize the absolute positional states of at least one or both
of the dose tracker and the preselector simultaneously or
concurrently. It is also conceivable, that the indicator assembly
or the remote indicator assembly of the injection device and/or of
the add-on device provide an alternating visualization of the
actual or momentary positional state of the dose tracker and the
preselection positional state of the preselector. The processor and
the electronic display may be configured to provide alternative
illustrations of the momentary preselection positional state and
the actual positional state of the dose tracker. Both indications,
e.g. provided in form of numbers or confirmation symbols may be
provided next to each other on the electronic display or in an
overlapping but temporally alternating way.
[0068] The first and second position sensors for determining a
positional state of the dose tracker and/or for determining the
preselection positional state of the preselector may comprise at
least one of electromechanical contact switches, a light detector,
such as a photodiode in connection with a light source and/or a
transmissive or reflective pattern on the dose tracker and the
preselector, respectively, a magnetic sensor in combination with a
magnetic encoding on at least one of the dose tracker and the
preselector or an electrically conductive structure on at least one
of the dose tracker and the preselector.
[0069] In the present context the term `distal` or `distal end`
relates to an end of the injection device that faces towards an
injection site of a person or of an animal. The term `proximal` or
`proximal end` relates to an opposite end of the injection device,
which is furthest away from an injection site of a person or of an
animal.
[0070] The term "drug" or "medicament", as used herein, means a
pharmaceutical formulation containing at least one pharmaceutically
active compound,
wherein in one embodiment the pharmaceutically active compound has
a molecular weight up to 1500 Da and/or is a peptide, a proteine, a
polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or
a fragment thereof, a hormone or an oligonucleotide, or a mixture
of the above-mentioned pharmaceutically active compound, wherein in
a further embodiment the pharmaceutically active compound is useful
for the treatment and/or prophylaxis of diabetes mellitus or
complications associated with diabetes mellitus such as diabetic
retinopathy, thromboembolism disorders such as deep vein or
pulmonary thromboembolism, acute coronary syndrome (ACS), angina,
myocardial infarction, cancer, macular degeneration, inflammation,
hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in
a further embodiment the pharmaceutically active compound comprises
at least one peptide for the treatment and/or prophylaxis of
diabetes mellitus or complications associated with diabetes
mellitus such as diabetic retinopathy, wherein in a further
embodiment the pharmaceutically active compound comprises at least
one human insulin or a human insulin analogue or derivative,
glucagon-like peptide (GLP-1) or an analogue or derivative thereof,
or exendin-3 or exendin-4 or an analogue or derivative of exendin-3
or exendin-4.
[0071] Insulin analogues are for example Gly(A21), Arg(B31),
Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28),
Pro(B29) human insulin; Asp(B28) human insulin; human insulin,
wherein proline in position B28 is replaced by Asp, Lys, Leu, Val
or Ala and wherein in position B29 Lys may be replaced by Pro;
Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human
insulin and Des(B30) human insulin.
[0072] Insulin derivates are for example B29-N-myristoyl-des(B30)
human insulin; B29-N-palmitoyl-des(B30) human insulin;
B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin;
B28-N-myristoyl LysB28ProB29 human insulin;
B28-N-palmitoyl-LysB28ProB29 human insulin;
B30-N-myristoyl-ThrB29LysB30 human insulin;
B30-N-palmitoyl-ThrB29LysB30 human insulin;
B29-N--(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;
B29-N--(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;
B29-N-(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and
B29-N-(.omega.-carboxyheptadecanoyl) human insulin.
[0073] Exendin-4 for example means Exendin-4(1-39), a peptide of
the sequence
H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Gl-
u-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-
Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
[0074] Exendin-4 derivatives are for example selected from the
following list of compounds: [0075] H-(Lys)4-des Pro36, des Pro37
Exendin-4(1-39)-NH2, [0076] H-(Lys)5-des Pro36, des Pro37
Exendin-4(1-39)-NH2, [0077] des Pro36 Exendin-4(1-39), [0078] des
Pro36 [Asp28] Exendin-4(1-39), [0079] des Pro36 [IsoAsp28]
Exendin-4(1-39), [0080] des Pro36 [Met(O)14, Asp28]
Exendin-4(1-39), [0081] des Pro36 [Met(O)14, IsoAsp28]
Exendin-4(1-39), [0082] des Pro36 [Trp(O2)25, Asp28]
Exendin-4(1-39), [0083] des Pro36 [Trp(O2)25, IsoAsp28]
Exendin-4(1-39), [0084] des Pro36 [Met(O)14 Trp(O2)25, Asp28]
Exendin-4(1-39), [0085] des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28]
Exendin-4(1-39); or [0086] des Pro36 [Asp28] Exendin-4(1-39),
[0087] des Pro36 [IsoAsp28] Exendin-4(1-39), [0088] des Pro36
[Met(O)14, Asp28] Exendin-4(1-39), [0089] des Pro36 [Met(O)14,
IsoAsp28] Exendin-4(1-39), [0090] des Pro36 [Trp(O2)25, Asp28]
Exendin-4(1-39), [0091] des Pro36 [Trp(O2)25, IsoAsp28]
Exendin-4(1-39), [0092] des Pro36 [Met(O)14 Trp(O2)25, Asp28]
Exendin-4(1-39), [0093] des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28]
Exendin-4(1-39), wherein the group -Lys6-NH2 may be bound to the
C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative
of the sequence [0094] des Pro36 Exendin-4(1-39)-Lys6-NH2
(AVE0010), [0095] H-(Lys)6-des Pro36 [Asp28]
Exendin-4(1-39)-Lys6-NH2, [0096] des Asp28 Pro36, Pro37,
Pro38Exendin-4(1-39)-NH2, [0097] H-(Lys)6-des Pro36, Pro38 [Asp28]
Exendin-4(1-39)-NH2, [0098] H-Asn-(Glu)5des Pro36, Pro37, Pro38
[Asp28] Exendin-4(1-39)-NH2, [0099] des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0100] H-(Lys)6-des Pro36, Pro37, Pro38
[Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0101] H-Asn-(Glu)5-des Pro36,
Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0102]
H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
[0103] H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25]
Exendin-4(1-39)-NH2, [0104] H-(Lys)6-des Pro36, Pro37, Pro38
[Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, [0105] H-Asn-(Glu)5-des
Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, [0106]
des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0107] H-(Lys)6-des Pro36, Pro37, Pro38
[Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0108]
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0109] H-(Lys)6-des Pro36 [Met(O)14,
Asp28] Exendin-4(1-39)-Lys6-NH2, [0110] des Met(O)14 Asp28 Pro36,
Pro37, Pro38 Exendin-4(1-39)-NH2, [0111] H-(Lys)6-desPro36, Pro37,
Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, [0112]
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2, [0113] des Pro36, Pro37, Pro38 [Met(O)14,
Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0114] H-(Lys)6-des Pro36,
Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, [0115]
H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0116] H-Lys6-des Pro36 [Met(O)14,
Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, [0117] H-des Asp28
Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2,
[0118] H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2, [0119] H-Asn-(Glu)5-des Pro36, Pro37, Pro38
[Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, [0120] des Pro36,
Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2, [0121] H-(Lys)6-des Pro36, Pro37, Pro38
[Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, [0122]
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2; or a pharmaceutically acceptable salt
or solvate of any one of the afore-mentioned Exendin-4
derivative.
[0123] Hormones are for example hypophysis hormones or hypothalamus
hormones or regulatory active peptides and their antagonists as
listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine
(Follitropin, Lutropin, Choriongonadotropin, Menotropin),
Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,
Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
[0124] A polysaccharide is for example a glucosaminoglycane, a
hyaluronic acid, a heparin, a low molecular weight heparin or an
ultra low molecular weight heparin or a derivative thereof, or a
sulphated, e.g. a poly-sulphated form of the above-mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof.
An example of a pharmaceutically acceptable salt of a
poly-sulphated low molecular weight heparin is enoxaparin
sodium.
[0125] Antibodies are globular plasma proteins (.about.150 kDa)
that are also known as immunoglobulins which share a basic
structure. As they have sugar chains added to amino acid residues,
they are glycoproteins. The basic functional unit of each antibody
is an immunoglobulin (Ig) monomer (containing only one Ig unit);
secreted antibodies can also be dimeric with two Ig units as with
IgA, tetrameric with four Ig units like teleost fish IgM, or
pentameric with five Ig units, like mammalian IgM.
[0126] The Ig monomer is a "Y"-shaped molecule that consists of
four polypeptide chains; two identical heavy chains and two
identical light chains connected by disulfide bonds between
cysteine residues. Each heavy chain is about 440 amino acids long;
each light chain is about 220 amino acids long. Heavy and light
chains each contain intrachain disulfide bonds which stabilize
their folding. Each chain is composed of structural domains called
Ig domains. These domains contain about 70-110 amino acids and are
classified into different categories (for example, variable or V,
and constant or C) according to their size and function. They have
a characteristic immunoglobulin fold in which two .beta. sheets
create a "sandwich" shape, held together by interactions between
conserved cysteines and other charged amino acids.
[0127] There are five types of mammalian Ig heavy chain denoted by
.alpha., .delta., .epsilon., .gamma., and .mu.. The type of heavy
chain present defines the isotype of antibody; these chains are
found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
[0128] Distinct heavy chains differ in size and composition;
.alpha. and .gamma. contain approximately 450 amino acids and
.delta. approximately 500 amino acids, while .mu. and .epsilon.
have approximately 550 amino acids. Each heavy chain has two
regions, the constant region (C.sub.H) and the variable region
(V.sub.H). In one species, the constant region is essentially
identical in all antibodies of the same isotype, but differs in
antibodies of different isotypes. Heavy chains .gamma., .alpha. and
.delta. have a constant region composed of three tandem Ig domains,
and a hinge region for added flexibility; heavy chains .mu. and
.epsilon. have a constant region composed of four immunoglobulin
domains. The variable region of the heavy chain differs in
antibodies produced by different B cells, but is the same for all
antibodies produced by a single B cell or B cell clone. The
variable region of each heavy chain is approximately 110 amino
acids long and is composed of a single Ig domain.
[0129] In mammals, there are two types of immunoglobulin light
chain denoted by .lamda. and .kappa.. A light chain has two
successive domains: one constant domain (CL) and one variable
domain (VL). The approximate length of a light chain is 211 to 217
amino acids. Each antibody contains two light chains that are
always identical; only one type of light chain, K or A, is present
per antibody in mammals.
[0130] Although the general structure of all antibodies is very
similar, the unique property of a given antibody is determined by
the variable (V) regions, as detailed above. More specifically,
variable loops, three each the light (VL) and three on the heavy
(VH) chain, are responsible for binding to the antigen, i.e. for
its antigen specificity. These loops are referred to as the
Complementarity Determining Regions (CDRs). Because CDRs from both
VH and VL domains contribute to the antigen-binding site, it is the
combination of the heavy and the light chains, and not either
alone, that determines the final antigen specificity.
[0131] An "antibody fragment" contains at least one antigen binding
fragment as defined above, and exhibits essentially the same
function and specificity as the complete antibody of which the
fragment is derived from. Limited proteolytic digestion with papain
cleaves the Ig prototype into three fragments. Two identical amino
terminal fragments, each containing one entire L chain and about
half an H chain, are the antigen binding fragments (Fab). The third
fragment, similar in size but containing the carboxyl terminal half
of both heavy chains with their interchain disulfide bond, is the
crystalizable fragment (Fc). The Fc contains carbohydrates,
complement-binding, and FcR-binding sites. Limited pepsin digestion
yields a single F(ab')2 fragment containing both Fab pieces and the
hinge region, including the H--H interchain disulfide bond. F(ab')2
is divalent for antigen binding. The disulfide bond of F(ab')2 may
be cleaved in order to obtain Fab'. Moreover, the variable regions
of the heavy and light chains can be fused together to form a
single chain variable fragment (scFv).
[0132] Pharmaceutically acceptable salts are for example acid
addition salts and basic salts. Acid addition salts are e.g. HCl or
HBr salts. Basic salts are e.g. salts having a cation selected from
alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other
mean: hydrogen, an optionally substituted C1-C6-alkyl group, an
optionally substituted C2-C6-alkenyl group, an optionally
substituted C6-C10-aryl group, or an optionally substituted
C6-C10-heteroaryl group. Further examples of pharmaceutically
acceptable salts are described in "Remington's Pharmaceutical
Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing
Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of
Pharmaceutical Technology.
[0133] Pharmaceutically acceptable solvates are for example
hydrates.
[0134] It will be further apparent to those skilled in the art that
various modifications and variations can be made to the injection
device without departing from the spirit and scope of what is
disclosed herein. Further, it is to be noted, that any reference
numerals used in the appended claims are not to be construed as
limiting the scope of the disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0135] In the following, embodiments of the drive mechanism and the
injection device are described in detail by making reference to the
drawings, in which:
[0136] FIG. 1 is a schematic representation of the injection device
comprising a dose tracker and a preselector,
[0137] FIG. 2 shows a configuration with the preselector in a first
preselection positional state and the dose tracker in a first
positional state and a corresponding configuration of the indicator
assembly,
[0138] FIG. 3 corresponds to FIG. 2 with the dose tracker in the
maximum dose positional state,
[0139] FIG. 4 is another configuration of the preselector in a
second preselection positional state and the dose tracker in a
first positional state smaller than the maximum dose positional
state,
[0140] FIG. 5 corresponds to FIG. 4 with the dose tracker in the
maximum dose positional state,
[0141] FIG. 6 shows another schematic example of an injection
device,
[0142] FIG. 7 shows another example of the injection device
connected or coupled with an add-on device,
[0143] FIG. 8 is a block diagram of an add-on device,
[0144] FIG. 9 is an exploded view of an injection device as handed
out to a patient,
[0145] FIG. 10 is an exploded view of the components that make up
the injection device according to FIG. 9,
[0146] FIG. 11 is a perspective view of another example of the
injection device comprising a preselector and an indicator
assembly,
[0147] FIG. 12 is a perspective enlarged view of the proximal end
of the device according to FIG. 11,
[0148] FIG. 13 is a perspective illustration of the device
according to FIGS. 11 and 12 with the housing partially cut
away,
[0149] FIG. 14 is an isolated view of a preselector,
[0150] FIG. 15 is a longitudinal cut through the proximal end of
the housing of the injection device according to FIGS. 11-13,
[0151] FIG. 16 is a side view of a proximal portion of the
injection device with the preselector in a minimum preselection
positional state,
[0152] FIG. 17 is the device according to FIG. 16 with the
preselector in an intermediate preselection positional state,
and
[0153] FIG. 18 is a side view of the injection device according to
FIGS. 16 and 17 with the preselector in a maximum preselection
positional state,
[0154] FIG. 19 is an isolated and perspective view of the dose
tracker,
[0155] FIG. 20 is another example of a proximal end of an injection
device comprising an electronically implemented indicator assembly
in an initial configuration with the preselector in a minimum
preselection positional state,
[0156] FIG. 21 is the device according to FIG. 20 with the dose
tracker and the dose dial in the maximum dose positional state,
[0157] FIG. 22 is the device according to FIGS. 20 and 21 with the
preselector in a maximum preselection positional state and with the
dose dial and the dose tracker in a zero dose configuration,
[0158] FIG. 23 is another configuration of the device according to
FIG. 22 with the dose tracker and the dose dialin a maximum dose
positional state,
[0159] FIG. 24 is a perspective view of the injection device
according to FIGS. 20-21 with the housing partially cut away,
[0160] FIG. 25 shows the indicator assembly of the device according
to FIGS. 20-24 detached from the housing of the injection
device,
[0161] FIG. 26 is another illustration of the injection device with
the indicator assembly provided in an add-on device detached from
the injection device,
[0162] FIG. 27 is a bottom view of the add-on device,
[0163] FIG. 28 is an enlarged illustration of the proximal portion
of the device according to FIG. 24,
[0164] FIG. 29 shows the interaction between a first position
sensor with the first marker on the dose tracker with the dose
tracker in an initial configuration,
[0165] FIG. 30 represents another configuration of the position
sensor according to FIG. 29 with the dose tracker in a first
positional state,
[0166] FIG. 31 shows the dose tracker in a second positional state
and
[0167] FIG. 32 shows the dose tracker in a third positional
state.
DETAILED DESCRIPTION
[0168] The schematic illustration of an injection device 1 in
accordance to FIG. 1 is rather simplified and is only used to
reveal and show the mutual interaction between a dose dial, a dose
tracker, a preselector and an indicator assembly of an injection
device. The injection device 1 comprises a housing 10. The housing
10 may be an elongated housing and may extend in a longitudinal or
axial direction (z). Inside the housing 10 there is typically
provided a reservoir or a cartridge 6 configured to contain and to
hold a liquid medicament. The housing 10 comprises a distal end 2
near a dispensing end of the cartridge 6. Opposite the distal end
the cartridge 6 is provided with a bung 7 that seals an interior of
the cartridge 6 in proximal direction. For expelling or dispensing
of a dose of the medicament from the interior of the cartridge 6
the injection device 1 comprises a drive mechanism 8. The drive
mechanism 8 comprises a piston rod 20 configured to exert a
distally directed pressure to the bung and in order to drive the
bung 7 in distal direction.
[0169] The injection device 1 also comprises a dose setting
mechanism 9. The dose setting mechanism comprises at least a dose
tracker 50. The dose tracker 50 is displaceable relative to the
housing 10. It is at least one of translationally or rotationally
displaceable relative to the housing 10 during setting of a dose.
Typically and during dose dispensing under the action of the drive
mechanism 8 the dose tracker 50 returns into a zero dose
configuration. In a subsequent dose setting procedure the dose
tracker 50 can be become repeatedly subject to at least one of a
translational or rotational displacement relative to the housing
10. The displacement of the dose tracker 50 during setting of a
dose is controllable or inducible by means of a dose dial 12 that
is displaceable relative to the housing 10 for setting of the dose.
For instance the dose dial 12 is rotationally supported on a
proximal end of the housing 10.
[0170] Insofar the illustration of FIG. 1 does not reflect the
relative positions of the various components of the injection
device relative to each other. The injection device 1 further
comprises a trigger 11 by way of which a dose dispensing action can
be triggered and/or controlled after a dose of appropriate size has
been set in a dose setting procedure. The trigger is operable
engageable with the drive mechanism for dispensing or expelling of
the dose.
[0171] In addition to the dose tracker 50 the injection device 1
comprises a preselector 70. The preselector 70 is configured to
define a maximum dose positional state 55 of the dose tracker
relative to the housing 10. The maximum dose positional state 55 is
that positional state of the dose tracker 50 that is furthest away
from a zero dose positional state of the dose tracker. The maximum
dose positional state 55 defines the maximum sized dose of a
medicament that can be dispensed with the injection device.
[0172] By means of the preselector 70 the maximum dose positional
state 55 and hence the maximum dose to be dispensed with the
injection device 1 can be varied and modified. Insofar the
preselector 70 provides a limiter or is a limiter for the dose
setting mechanism 9. The dose setting mechanism 9 and the dose
tracker 50 may be originally configured and designed to provide a
selection of doses of variable size. With the preselector 70 only
one or a few predefined doses among a range of differently sized
doses that could be originally dispensed with the injection device
1 are pre-set. Hence, by means of the preselector 70 the capability
of the dose setting mechanism 9 to set and to select numerous
differently sized doses is reduced to only one or a few differently
sized doses of the medicament.
[0173] Insofar and by means of the preselector 70 the injection
device 1 can be transformed or transferred into a kind of a fixed
dose injection device. This is of particular benefit for situations
where the user himself should not decide about the size of a dose
of the medicament to be administered. From a user perspective the
preselector therefore facilitates overall usage and handling of the
injection device.
[0174] Typically, the preselector 70 and the dose tracker 50 are
configured to mechanically engage. The dose tracker 50 may comprise
at least one tracking stop feature 51 and the preselector may
comprise at least one preselector stop feature 73. By means of the
preselector stop feature 73 the preselector 70 mechanically engages
with the correspondingly shaped tracking stop feature 51 of the
dose tracker 50. In this way a displacement of the dose tracker 50
beyond the maximum dose positional 55 state can be blocked and
prevented. The preselector 70 may be only operable by caregivers or
medical staff. It may be protected against misuse and may not be
operable or actuatable or reconfigurable by the end user or
patient. However and according to an individual prescription
schedule or medication schedule the care giver may individually
modify or configure the preselector 70 so that the injection device
becomes capable to dispense and to expel a dose of required
size.
[0175] The injection device 1 further comprises an indicator
assembly 90 by way of which at least a relative position of the
dose tracker 50 relative to the preselector 70 can be indicated.
Since the device 1 is limited to expel or to dispense only a single
sized dose of known size the injection device 1 may be void of a
specific dose indicating mechanism, e.g. illustrating the dose size
in terms of units of the medicament, such as international units of
insulin. It is not required for the indicator assembly 90 to
visualize or illustrate a number of units of the medicament
actually set. Since the injection device can be limited or
restricted to the dispensing or expelling of multiple doses of
equal size that particular size is known to at least the caregiver.
It is hence sufficient for the patient when the indicator assembly
has a limited function and is only capable to provide a comparison
between the actual positional state 54 of the dose tracker compared
to the predefined maximum dose positional state 55 of the dose
tracker 50.
[0176] In FIG. 2 a configuration is illustrated wherein the
preselector 70 is in a first preselection positional state 110. The
length of the arrow representing the first preselection positional
state 110 is indicative of the path length the dose dial 12 or the
dose tracker 50 may be displaced starting from a zero dose
configuration until reaching a maximum dose positional state 55. In
the configuration according to FIG. 2 the momentary positional
state 54 of the dose tracker 50 is also illustrated. This arrow is
shorter than the arrow representing the first preselection
positional state 110. Accordingly, the indicator assembly 90 as
shown in FIG. 2 provides an indication 91 that the maximum dose
positional state 55 has not yet been reached. For example the
indication 91 is illustrated as a curved arrow indicating to a user
of the injection device to dial the dose dial 12 further in a dose
incrementing direction, e.g. clockwise.
[0177] In the configuration according to FIG. 3 the dose dial 12
and hence the dose tracker 50 have been further displaced. Here,
the positional state 54 of the dose tracker 50 coincides and
corresponds to the maximum dose positional state 55. Accordingly
the indicator assembly 90 provides a first marker 85, e.g. in form
of a second indication 92 that represents a confirmation that the
dose tracker 50 has reached the maximum dose positional state
55.
[0178] The illustration of FIG. 4 is somewhat comparable to the
configuration of FIG. 2. The configuration as illustrated in FIG. 5
is somewhat comparable to the configuration of FIG. 3. In FIG. 4
the preselector 70 has been moved to a second preselection
positional state 110'. In comparison to FIG. 2 the second
preselection positional state 110' represents a larger maximum dose
of the medicament to be expelled. Also here, the reduced length of
the arrow representing the actual positional state 54 of the dose
tracker 50 illustrates that the dose tracker 50 has not yet reached
the maximum dose positional state 55. Accordingly, the indicator
assembly 90 provides a first indicator 191 that differs from a
second indicator 192 as illustrated in FIG. 5. Also here, the
second indicator 192 represents a first marker 85 that is
indicative that the dose tracker 50 has reached the maximum dose
positional state 55. The indicators 90, 91, 191, 192 may comprise
symbols, numbers, letters or just a differently colored structure
in order to distinguish between the maximum dose positional state
of the dose tracker and a non-maximum dose positional state of the
dose tracker.
[0179] With the present injection device 1 injection and hence
dispensing of the dose should only be triggered and commence when
the dose tracker has reached the maximum dose positional state
55.
[0180] The preselector 70 is at least one of translationally or
rotationally displaceable relative to the housing 10 between the at
least two preselection positional states 110, 110'. In any of the
available preselection positional states 110, 110' the preselector
is lockable relative to the housing 10. Hence during dose setting
the preselector 70 is stationary or fixed to the housing 10 while
the dose tracker 50 is subject to at least one of a translational
or rotational displacement relative to the housing 10.
[0181] The schematic illustration of the injection device 1
directly corresponds to the implementation of an injection device
as described later with regard to FIGS. 9-19. Here, the indicator
assembly 90 is integrated or connected to the preselector 70. The
dose tracker is provided with at least a first marker 85. The
indicator assembly 90 is configured to reveal the first marker 85
on the dose tracker 50 when the dose tracker 50 reaches the maximum
dose positional state 55. In the maximum dose positional state 55
the relative position or orientation of the first marker coincides
or aligns with the position of the indicator assembly 90. In this
way and when reaching the maximum dose positional state 55 the at
least first marker 85 is revealed by the indicator assembly 90. For
instance, the indicator assembly 90 may comprise an aperture 75
through which aperture the dose tracker or at least a portion
thereof, namely a portion provided with the first marker 85 is
discernible.
[0182] In the schematic representation of FIG. 6 the indicator
assembly 190 is implemented as an electronic indicator assembly.
The indicator assembly 190 may interact separately with the dose
tracker 150 and with the preselector 170. For instance, the
indicator assembly 190 may be configured to determine the
preselection positional state 110 of the preselector 170 separate
from the positional state 54 of the dose tracker 150. Here, the
indicator assembly 190 does not have to be integrated or connected
to the preselector 170. The indicator assembly 190 may be located
elsewhere in or on the housing 10 of the injection device 1.
[0183] Typically, the indicator assembly 190 comprises a first
position sensor 430 configured to determine or to detect a
positional state of the dose tracker 150. The indicator assembly
190 may comprise a second position sensor 390 configured to
determine or to detect a positional state of the preselector 170.
Moreover, the electronically implemented indicator assembly 190 may
comprise a processor 420 to process signals obtainable from the
first position sensor 390 and obtainable from the second position
sensor 430.
[0184] The processor 420 may be configured to compare the
positional state of the dose tracker 150. If the processor 420
determines that the positional state of the dose tracker 150
corresponds to the maximum dose positional state 55 as governed and
defined by the momentary preselection positional state 110 of the
preselector 70 the processor 420 is configured go provide a
respective indicator on an electronic display 410 of the indicator
assembly 190. The indicator assembly 190 may further comprise a
communication unit 440, e.g. implemented in form of an antenna to
receive and/or to transmit electronic data or signals. By means of
the communication unit 440 the indicator assembly 190 may exchange
data with an external electronic device 500.
[0185] The external electronic device 500 may be implemented as a
smartphone. The external electronic device may comprise a portable
electronic device. It may be provided with a software or a software
application that is configured to communicate with the
communication unit 440 in a wireless way.
[0186] The drive mechanism 8 and the dose setting mechanism 9 as
well as the preselector 170 and the dose tracker 150 do not have to
be implemented all mechanically. At least one of the drive
mechanism 8, the dose setting mechanism 9, the dose tracker 150 and
the preselector 170 may be implemented electromechanically. In this
way the indicator assembly 190 or its processor 420 can be
configured to reconfigure the preselector 170. For instance, the
external electronic device 500 may be configured to communicate
with the processor 420 via the communication unit 440 to modify the
configuration of the preselector 170. When implemented as an
electromechanical dose setting mechanism 9 the preselector 170 may
be electronically implemented and may be reconfigurable remotely by
means of at least one of the electronic device 500 and the
processor 420.
[0187] In FIG. 7 another embodiment of the injection device 1 is
illustrated. Here, the indicator assembly 190 is not integrated
into the device 1 but is provided as a remote indicator assembly
490 that is provided in or on an add-on device 400. The add-on
device 400 is configured for detachable attachment to the housing
10 of the injection device 1. The add-on device 400 comprises all
those features and components of the electronic indicator assembly
190 as described above in connection with FIG. 6. The detachable
add-on device 400 is particularly configured and dedicated for use
with injection devices 1 that are configured as disposable
injection devices and which are intended to be discarded entirely
once the medicament has been used up.
[0188] In FIG. 8 a rather schematic illustration of the add-on
device 400 is provided. The add-on device 400 comprises the remote
indicator assembly 490 that is configured to visualize or to
indicate audibly or haptically to a user that a maximum dose
positional state 55 of the dose tracker 150 has been reached. The
electronic display 410 may comprise a so called electronic paper or
e-paper display device that mimics the appearance of ordinary ink
on paper. The electronic display 410 may comprise one of an
electrophoretic display, a micro encapsulated electrophoretic
display, an electrowetting display, an electrofluidic display and a
plasmonic electronic display. Such electronic paper displays only
consume a minimum of electric energy.
[0189] The communication unit 440 may comprise an antenna, such as
an RFID antenna. The external electronic device 500 may comprise an
RFID reader configured to wirelessly provide and to wirelessly
transfer electric energy to the remote indicator assembly 490.
Alternative or additional the communication unit 440 may comprise
other radio frequency based antennas that may be configured to
support one of a WLAN, Wi-Fi or Bluetooth communication protocol.
In this way the processor 420 and the electronic display 410 may
receive sufficient power for visualizing or for generally
indicating the positional state of the dose tracker 150 relative to
the preselector 170. The add-on device 400 and/or the remote
indicator assembly 490 may also comprise at least one actuation
element 450, in form of at least one or several buttons. The
actuation element 450 may be also integrated into the electronic
display 410. Here, the electronic display 410 may comprise a touch
sensitive display.
[0190] By means of the actuation element 450 a user may confirm
that a dose dispensing operation has just been conducted. Also
during dispensing or during dose setting the user may press on the
actuation element 450 thus inducing a change of the visual
appearance of the electronic display 410. In this way, the
electronic display 410 may alternately provide information
regarding the preselection positional state and a momentary
positional state of the dose tracker.
[0191] In the following an example of a handheld and all
mechanically implemented injection device 1 is described with
regard to FIGS. 9 and 10.
[0192] The injection device 1 as shown in FIGS. 9 and 10 is a
pre-filled disposable injection device that comprises a housing 10
to which an injection needle 15 can be affixed. The injection
needle 15 is protected by an inner needle cap 16 and either an
outer needle cap 17 or a protective cap 18 that is configured to
enclose and to protect a distal section of the housing 10 of the
injection device 1. The housing 10 may comprise and form a main
housing part configured to accommodate a drive mechanism 8 as shown
in FIG. 10. The injection device 1 may further comprise a distal
housing component denoted as cartridge holder 14. The cartridge
holder 14 may be permanently or releasably connected to the main
housing 10. The cartridge holder 14 is typically configured to
accommodate a cartridge 6 that is filled with a liquid medicament.
The cartridge 6 comprises a cylindrically-shaped or tubular-shaped
barrel 25 sealed in proximal direction 3 by means of a bung 7
located inside the barrel 25. The bung 7 is displaceable relative
to the barrel 25 of the cartridge 6 in a distal direction 2 by
means of a piston rod 20. A distal end of the cartridge 6 is sealed
by a pierceable seal 26 configured as a septum and being pierceable
by a proximally directed tipped end of the injection needle 15. The
cartridge holder 14 comprises a threaded socket 28 at its distal
end to threadedly engage with a correspondingly threaded portion of
the injection needle 15. By attaching the injection needle 15 to
the distal end of the cartridge holder 14 the seal 26 of the
cartridge 6 is penetrated thereby establishing a fluid transferring
access to the interior of the cartridge 6.
[0193] When the injection device 1 is configured to administer e.g.
human insulin, the dosage set by a dial 12 at a proximal end of the
injection device 1 may be displayed in so-called international
units (IU, wherein 1 IU is the biological equivalent of about 45.5
.mu.g of pure crystalline insulin (1/22 mg).
[0194] As shown further in FIGS. 9 and 10, the housing 10 comprises
a dosage window 13 that may be in the form of an aperture in the
housing 10. The dosage window 13 permits a user to view a limited
portion of a number sleeve 80 that is configured to move when the
dial 12 is turned, to provide a visual indication of a currently
set dose. The dial 12 is rotated on a helical path with respect to
the housing 10 when turned during setting and/or dispensing or
expelling of a dose.
[0195] The injection device 1 may be configured so that turning the
dosage knob 12 causes a mechanical click sound to provide
acoustical feedback to a user. The number sleeve 80 mechanically
interacts with a piston in the insulin cartridge 6. When the needle
15 is stuck into a skin portion of a patient, and when the trigger
11 or injection button is pushed, the insulin dose displayed in
display window 13 will be ejected from injection device 1. When the
needle 15 of the injection device 1 remains for a certain time in
the skin portion after the trigger 11 is pushed, a high percentage
of the dose is actually injected into the patient's body. Ejection
of an insulin dose may also cause a mechanical click sound, which
is however different from the sounds produced when using the dial
12.
[0196] In this embodiment, during delivery of the insulin dose, the
dial 12 is turned to its initial position in an axial movement,
that is to say without rotation, while the number sleeve 80 is
rotated to return to its initial position, e.g. to display a dose
of zero units.
[0197] The injection device 1 may be used for several injection
processes until either the cartridge 6 is empty or the expiration
date of the medicament in the injection device 1 (e.g. 28 days
after the first use) is reached.
[0198] Furthermore, before using injection device 1 for the first
time, it may be necessary to perform a so-called "prime shot" to
remove air from the cartridge 6 and the needle 15, for instance by
selecting two units of the medicament and pressing trigger 11 while
holding the injection device 1 with the needle 15 upwards. For
simplicity of presentation, in the following, it will be assumed
that the ejected amounts substantially correspond to the injected
doses, so that, for instance the amount of medicament ejected from
the injection device 1 is equal to the dose received by the
user.
[0199] The expelling or drive mechanism 8 as illustrated in more
detail in FIG. 10 comprises numerous mechanically interacting
components. A flange like support of the housing 10 comprises a
threaded axial through opening threadedly engaged with a first
thread or distal thread 22 of the piston rod 20. The distal end of
the piston rod 20 comprises a bearing 21 on which a pressure foot
23 is free to rotate with the longitudinal axis of the piston rod
20 as an axis of rotation. The pressure foot 23 is configured to
axially abut against a proximally facing thrust receiving face of
the bung 7 of the cartridge 6. During a dispensing action the
piston rod 20 rotates relative to the housing 10 thereby
experiencing a distally directed advancing motion relative to the
housing 10 30 and hence relative to the barrel 25 of the cartridge
6. As a consequence, the bung 7 of the cartridge 6 is displaced in
distal direction 2 by a well-defined distance due to the threaded
engagement of the piston rod 20 with the housing 10.
[0200] The piston rod 20 is further provided with a second thread
24 at its proximal end. The distal thread 22 and the proximal
thread 24 are oppositely handed.
[0201] There is further provided a drive sleeve 30 having a hollow
interior to receive the piston rod 20. The drive sleeve 30
comprises an inner thread threadedly engaged with the proximal
thread 24 of the piston rod 20. Moreover, the drive sleeve 30
comprises an outer threaded section 31 at its distal end. The
threaded section 31 is axially confined between a distal flange
portion 32 and another flange portion 33 located at a predefined
axial distance from the distal flange portion 32. Between the two
flange portions 32, 33 there is provided a last dose limiter 35 in
form of a semi-circular nut having an internal thread mating the
threaded section 31 of the drive sleeve 30.
[0202] The last dose limiter 35 further comprises a radial recess
or protrusion at its outer circumference to engage with a
complementary-shaped recess or protrusion at an inside of the
sidewall of the housing 10. In this way the last dose limiter 35 is
splined to the housing 10. A rotation of the drive sleeve 30 in a
dose incrementing direction 4 or clockwise direction during
consecutive dose setting procedures leads to an accumulative axial
displacement of the last dose limiter 35 relative to the drive
sleeve 30. There is further provided an annular spring 40 that is
in axial abutment with a proximally facing surface of the flange
portion 33. Moreover, there is provided a tubular-shaped clutch 60.
At a first end the clutch 60 is provided with a series of
circumferentially directed saw teeth. Towards a second opposite end
of the clutch 60 there is located a radially inwardly directed
flange.
[0203] Furthermore, there is provided a dose dial sleeve also
denoted as number sleeve 80. The number sleeve 80 is provided
outside of the spring 40 and the clutch 60 and is located radially
inward of the housing 10. A helical groove 81 is provided about an
outer surface of the number sleeve 80. The housing 10 is provided
with the dosage window 13 through which a part of the outer surface
of the number 80 can be seen. The housing 10 is further provided
with a helical rib at an inside sidewall portion of an insert piece
62, which helical rib is to be seated in the helical groove 81 of
the number sleeve 80. The tubular shaped insert piece 62 is
inserted into the proximal end of the housing 10. It is
rotationally and axially fixed to the housing 10. There are
provided first and second stops on the housing 10 to limit a dose
setting procedure during which the number sleeve 80 is rotated in a
helical motion relative to the housing 10. As will be explained
below in greater detail, at least one of the stops is provided by a
preselector stop feature 73 provided on a preselector 70.
[0204] The dose dial 12 in form of a dose dial grip is disposed
about an outer surface of the proximal end of the number sleeve 80.
An outer diameter of the dose dial 12 typically corresponds to and
matches with the outer diameter of the housing 10. The dose dial 12
is secured to the number 80 to prevent relative movement
therebetween. The dose dial 12 is provided with a central
opening.
[0205] The trigger 11, also denoted as dose button is substantially
T-shaped. It is provided at a proximal end of the injection device
10. A stem 64 of the trigger 11 extends through the opening in the
dose dial 12, through an inner diameter of extensions of the drive
sleeve 30 and into a receiving recess at the proximal end of the
piston rod 20. The stem 64 is retained for limited axial movement
in the drive sleeve 30 and against rotation with respect thereto. A
head of the trigger 11 is generally circular. The trigger side wall
or skirt extends from a periphery of the head and is further
adapted to be seated in a proximally accessible annular recess of
the dose dial 12.
[0206] To dial a dose a user rotates the dose dial 12. With the
spring 40 also acting as a clicker and the clutch 60 engaged, the
drive sleeve 30 the spring or clicker 40, the clutch 60 and the
number sleeve 80 rotate with the dose dial 12. Audible and tactile
feedback of the dose being dialed is provided by the spring 40 and
by the clutch 60. Torque is transmitted through saw teeth between
the spring 40 and the clutch 60. The helical groove 81 on the
number sleeve 80 and a helical groove in the drive sleeve 30 have
the same lead. This allows the number sleeve 80 to extend from the
housing 10 and the drive sleeve 30 to climb the piston rod 20 at
the same rate. At a limit of travel a radial stop on the number
sleeve 80 engages either with a first stop or a second stop
provided on the housing 10 provided on the pre-selector 70 to
prevent further movement in a dose incrementing direction 4.
Rotation of the piston rod 20 is prevented due to the opposing
directions of the overall and driven threads on the piston rod
20.
[0207] The last dose limiter 35 keyed to the housing 10 is advanced
along the threaded section 31 by the rotation of the drive sleeve
30. When a final dose dispensed position is reached, a radial stop
formed on a surface of the last dose limiter 35 abuts a radial stop
on the flange portion 33 of the drive sleeve 30, preventing both,
the last dose limiter 35 and the drive sleeve 30 from rotating
further.
[0208] Should a user inadvertently dial beyond the desired dosage,
the injection device 1, configured as a pen-injector allows the
dosage to be dialed down without dispense of the medicament from
the cartridge 6. For this the dose dial 12 is simply
counter-rotated. This causes the system to act in reverse. A
flexible arm of the spring or clicker 40 then acts as a ratchet
preventing the spring 40 from rotating. The torque transmitted
through the clutch 60 causes the saw teeth to ride over one another
to create the clicks corresponding to dialed dose reduction.
Typically, the saw teeth are so disposed that a circumferential
extent of each saw tooth corresponds to a unit dose.
[0209] When the desired dose has been dialed the user may simply
dispense the set dose by depressing the trigger 11. This displaces
the clutch 60 axially with respect to the number sleeve 80 causing
dog teeth thereof to disengage. However, the clutch 60 remains
keyed in rotation to the drive sleeve 30. The number sleeve 80 and
the dose dial 12 are now free to rotate in accordance with the
helical groove 81.
[0210] The axial movement deforms the flexible arm of the spring 40
to ensure the saw teeth cannot be overhauled during dispense. This
prevents the drive sleeve 30 from rotating with respect to the
housing 10 though it is still free to move axially with respect
thereto. The deformation is subsequently used to urge the spring 40
and the clutch 60 back along the drive sleeve 30 to restore the
connection between the clutch 60 and the number sleeve 80 when the
distally directed dispensing pressure is removed from the trigger
11.
[0211] The longitudinal axial movement of the drive sleeve 30
causes the piston rod 20 to rotate through the through opening of
the support of the housing 10, thereby to advance the bung 7 in the
cartridge 6. Once the dialed dose has been dispensed, the number
sleeve 80 is prevented from further rotation by contact of at least
one stop extending from the dose dial 12 with at least one
corresponding stop of the housing 10. A zero dose position may be
determined by the abutment of one of axially extending edges or
stops of the number sleeve 80 with at least one or several
corresponding stops of the housing 10.
[0212] The expelling mechanism or drive mechanism 8 as described
above is only exemplary for one of a plurality of differently
configured drive mechanisms that are generally implementable in a
disposable pen-injector. The drive mechanism as described above is
explained in more detail e.g. in WO2004/078239A1, WO 2004/078240A1
or WO 2004/078241A1 the entirety of which being incorporated herein
by reference.
[0213] The injection device 1 further comprises a preselector 70
that is configured to define a maximum dose positional state 55 of
the number sleeve 80. Here, the number sleeve 80 represents or
substitutes the dose tracker 50 as described above. Although and in
view of the indicator assembly 90 the number sleeve is no longer
required to illustrate dose indicating numbers in the dosage window
13 of the housing 10. The dose tracker 50 and hence the number
sleeve 80 comprises a tracking stop feature 51 to engage with a
correspondingly shaped preselector stop feature 73 as will be
described in greater detail with regard to FIG. 13.
[0214] As shown in FIGS. 11-13 the dose setting mechanism 9
comprises a preselector 70 that is at least one of translationally
or rotationally displaceable relative to the housing 10 and hence
relative to the sidewall 48 of the housing 10 between at least two
preselection positional states 110, 110' and 110'' as illustrated
in the sequence of FIGS. 16, 17 and 18. The preselector 70 behaves
as a limiter and provides a limiter function in order to delimit a
displacement of the dose tracker 50 relative to the housing 10. The
preselector 70 comprises a sleeve portion 71 enclosing at least a
longitudinal section of the dose tracker 50 and hence of the number
sleeve 80. Near an axial end the sleeve portion 71 comprises a
preselector stop feature 73 in the form of an axial protrusion with
a side edge extending parallel to the longitudinal axis of the
housing 10.
[0215] The dose tracker 50 comprises a correspondingly shaped
tracking stop feature 51. As shown in FIG. 13 there is a predefined
axial distance between the tracking stop feature 51 and the
preselector stop feature 73. The preselector 70 is hindered from
rotation relative to the housing 10. It comprises a spline feature
74, which is in the form of a longitudinal protrusion received in a
correspondingly shaped recess on an inside facing section of the
sidewall 48 of the housing 10. In this way the preselector 70 is
permanently rotationally locked to the housing 10. With the spline
feature 74 the preselector 70 and its sleeve portion 71 is free to
slide in axial or longitudinal direction relative to the housing
10. For providing a keyed engagement between the sleeve portion 71
and the housing 10 also the housing 10 may comprise a radially
inwardly extending protrusion to slide in a groove or slot on the
outside surface of the sleeve portion 71.
[0216] The preselector 70 further comprises a slider 72 that is
accessible from outside the housing 10. The slider 72 can be
integrally formed with the sleeve portion 71. The sleeve portion 71
and the slider 72 may be also provided as separate pieces that are
connected together by mutually corresponding connectors, not
explicitly illustrated here. The slider 72 is axially guided along
a displacement path 49 formed by a recess 41 on an outside facing
surface portion of the sidewall 48 of the housing 10. The recess 41
may be circumferentially confined by a surrounding edge 44 forming
a stepped down portion in the outside surface of the sidewall 48.
The recess 41 comprises a through opening 42 as indicated in FIG.
13. The through opening 42 is formed in a bottom section 43 of the
recess. The through opening 42 comprises a longitudinal slit
through which the interconnection of the sleeve portion 71 and the
slider 72 extends. On the outside surface the slider 72 has a
gripping structure 77 featuring various protrusions that are
separated in axial direction so as to provide a rather slip-free
engagement, e.g. with a finger of a hand of a user.
[0217] The preselector 70 further comprises a detent structure 76
best shown in FIG. 15. The detent structure 76 is configured to
engage with a correspondingly shaped counter detent structure 46
provided on the sidewall 48 of the housing 10. The counter detent
structure 46 comprises at least two recesses 47 that are separated
from each other along the longitudinal axis. The detent structure
76 of the preselector 70 comprises a resiliently deformable snap
feature, such as a radially deformable tongue to mechanically
engage with one of the recesses 47 of the counter detent structure
46 of the housing 10. In this way the preselector 70 is
displaceable relative to the housing between at least two
preselection positional states 110, 110', 110''. In any of the
preselection positional states 110, 110', 110'' the preselector 70
is locked to the housing. In order to displace the preselector 70
relative to the housing, e.g. from one preselection positional
state 110 to another preselection positional state 110' the holding
force acting between and provided by the detent structure 76 and
the counter detent structure 46 must be overcome.
[0218] The axial position of the preselector 70 determines a
maximum distance the dose tracker 50 can be displaced starting from
a zero dose configuration as shown in FIG. 13, 16, 17 or 18 to a
maximum dose configuration in which the dose tracker 50 protrudes
from a proximal end of the housing 10 until the tracking stop
feature 51 abuts with the preselector stop feature 73 thus blocking
any further proximally directed and dose increasing rotation of the
dose tracker 50 in unison with the dose dial 12.
[0219] The dose tracker 50 and hence the number sleeve 80 comprises
a helical groove 81 engaged with a correspondingly shaped
protrusion 63 provided at the proximal end of the housing 10. The
protrusion 63 may be provided on an inside facing surface portion
of the insert 62 fixed to the proximal end of the housing 10. The
insert facilitates assembly of the components inside the housing of
the injection device.
[0220] Also a portion of the bottom section 43 and hence of the
recess 41 may be provided by the insert 62. The insert 62 may
provide a proximal end cap of the housing 10 of the injection
device 1.
[0221] The preselector 70 is arrestable or fixable to the sidewall
48 of the housing 10 in at least two different discrete positions
denoted as preselection positional states 110, 110', 110''. The
axial distance between neighboring preselection positional states
110, 110' is identical and corresponds to the longitudinal
advancing motion of the dose tracker 50 as the dose tracker 50
undergoes a complete revolution relative to the housing 10. In this
way it is guaranteed, that the tracking stop feature 51 always
exactly engages with the preselector stop feature 73 when reaching
the maximum dose positional state 55.
[0222] In the configuration as shown in FIG. 16 the dose tracker 50
can be rotated at least by one complete revolution until its
tracking stop feature 51 abuts and engages with the preselector
stop feature 73. By displacing the preselector 70 to the next
preselection positional state 110 as shown in FIG. 17, the dose
tracker 50 can be rotated at least by two complete revolutions
until the tracking stop feature 51 and the preselector stop feature
73 mechanically engage thereby blocking any further dose increasing
displacement of the dose tracker 50 and hence of the dose dial
12.
[0223] In the configuration of FIG. 18 the preselector 70 is in the
most proximal position of three discrete allowable and supported
preselection positional states 110, 110', 110''. In this position
of the preselector 70 the dose tracker 50 can be rotated at least
by three complete revolutions relative to the housing 10.
[0224] In FIG. 19 an isolated view of the dose tracker 50 in form
of the number sleeve 80 is provided. As shown there the outside
surface of the dose tracker 50 comprises a first marker 85. The
first marker 85 comprises a first surface section 82 that may be
provided with a first indication 91. The marker 85 comprises a
second surface section 84 non-overlapping with the first surface
section 82. The second surface section 84 may be provided with a
second indication 92. As already described in connection with FIGS.
2 and 3 first and second indications 91, 92 may comprise different
symbols or different colors.
[0225] The second surface section 84 and hence the second
indication 92 may provide a confirmation symbol indicating to the
end user that the dose tracker 50 has reached the predefined
maximum dose positional state 55. The second surface section 84 and
the second indication 92 are arranged in such a distance to the
tracking stop feature 51 which distance substantially corresponds
to the longitudinal distance between the preselector stop feature
73 and an aperture 75 provided in the preselector 70. The aperture
75 extends radially through the preselector 70. The aperture 75 may
extend through an overlapping portion of the sleeve portion 71 and
the slider 72. As illustrated in FIG. 16 the aperture 75 may be
provided with a magnifying lens 78.
[0226] In this way and when reaching the maximum dose positional
state 55 in which the tracking stop feature 51 engages with the
preselector stop feature 73 the second surface portion 84 and hence
the second indication 92 overlaps with and aligns with the aperture
75 so that the second surface portion 84 and the second indication
92 provided thereon becomes discernible and visible through the
aperture 75. This is an indication to the end user that the maximum
dose positional state 55 has been reached.
[0227] Before reaching the maximum dose positional state 55 the
first surface portion 82, eventually with the first indication 91
is revealed in the aperture 75 thus indicating to the user that the
maximum dose positional state 55 has not yet been reached and that
dispensing should not yet commence.
[0228] On an outside surface of the sidewall 48 of the housing 10
there is further provided at least one preselection indication 45.
Apparently and as illustrated in FIGS. 11 and 12 there are provided
three consecutive preselection indications 45. The preselection
indications 45 comprise a triangular shaped pointer in combination
with a number, e.g. 1, 2, 3. The preselection indications 45 are
arranged along the displacement path 49 of the preselector 70 and
hence of its slider 72. Near or aligned with the aperture 75 there
is further provided a pointer 79. Since the preselection
indications 45 are separated along the displacement path 49 of the
preselector 70 in any one of the preselection positional states
110, 110', 110'' the pointer 79 points to one of the preselection
indications 45. The preselection indication 45 in the present
embodiment corresponds to the total number of revolutions of the
dose tracker 50 for the respective preselection positional state.
However, the preselection indication 45 may also represent standard
units of the medicament to be dispensed or may provide any other
dose size indicating symbol.
[0229] In the sketches of FIGS. 11 and 12 the preselector 70 is in
the largest preselection positional state 110''. Accordingly, the
pointer 79 is in alignment with the largest preselection indication
45, namely with number 3.
[0230] The position of the preselector 70 relative to the housing
10 is therefore indicative of the maximum dose that can be set with
the dose setting mechanism 9. The indicator assembly 90 presently
integrated into the preselector 70 is then indicative, that the
momentary configuration and status of the dose setting mechanism 9
corresponds to the pre-set dose.
[0231] Even though the presently illustrated embodiments only show
a fixing or locking of the limiter 70 or the preselector 70 at
discrete positions relative to the housing 10 that correspond to
consecutive and complete revolutions of the dose tracker 50 it is
also conceivable that the dose tracker 50 comprises two or even
three tracking stop features 51 to engage with the limiter stop
feature or preselector stop feature 73. Alternatively also the
preselector 70 may comprise two or more preselector stop feature 73
to engage with the tracking stop feature 51. In this way the
maximum dose positional state could be assigned with every half or
every third revolution of the dose tracker 50 relative to the
housing 10. Furthermore it is conceivable, that two or more
tracking stop feature 51 simultaneously engage with correspondingly
shaped two or more preselector stop feature 73. In this way the
mechanical interaction and robustness of the abutment between the
dose tracker 50 and the preselector 70 can be enhanced and
increased.
[0232] FIGS. 20-24 show another example of an injection device.
Here and contrary to the injection device 1 as described in
connection with FIGS. 11-19 the indicator assembly 190 is
implemented as an electronic indicator assembly. As shown in FIG.
20 the electronic indicator assembly 190 comprises an electronic
display 410 having a first display section 412 and having a second
display section 414. The display 410 is typically provided on or
near a proximal end of the housing 10. The preselector 170 is all
mechanically implemented as already described in connection with
FIGS. 11-19. Also here the preselector 170 comprises a sleeve
portion 171 that is rotationally locked to the housing 10 by means
of a spline feature 174 on an outside surface of the sleeve portion
171.
[0233] The sleeve portion 171 encloses a portion of an outside
surface of the dose tracker 150. Also here the dose tracker 150
comprises a number sleeve 180. The dose tracker 150 also comprises
a tracking stop feature 151 to abut and to engage with a
correspondingly shaped preselector limiting stop feature 173. The
sleeve portion 171 is connected to a slider 172 having a gripping
structure 177 on an outside facing surface section. The slider also
comprises a pointer 179 to point to one of the three preselection
indications 45 that are arranged along the displacement path 49 of
the slider 172. Even though not illustrated in detail the
preselector 70 and the housing 10 comprise a detent structure 76
and a counter detent structure 46 as described in connection with
FIGS. 14 and 15 above.
[0234] In this way the preselector 170 can be fixed and locked to
the sidewall 48 of the housing 10 in any of the available
preselection positional states 110, 110', 110''.
[0235] Contrary to the example as shown in FIGS. 11-19 the
indicator assembly 190 is provided separate from the preselector
170. For this the indicator assembly 190 comprises a first position
sensor 430 and a second position sensor 390 as illustrated in FIG.
27. The first position sensor 430 is configured to determine or to
detect a positional state of the dose tracker 150 relative to the
housing 10. The second position sensor 390 is configured to
determine and to detect a preselection positional state of the
preselector 70. Both position sensors 430, 390 are configured to
generate electric signals being indicative of the detected position
of the dose tracker 150 and the preselector 170.
[0236] The indicator assembly 190 further comprises a processor 420
connected to the first position sensor 430 and connected to the
second position sensor 390. In this way the indicator assembly 190
is enabled to compare a measured or detected positional state 54 of
the dose tracker 150 with the preselection positional state 110 of
the preselector 170. Depending on the comparison the electronically
implemented indicator assembly 190 is configured to provide one of
at least two indicators 191, 192 as shown in FIGS. 20 and 21. In
FIG. 20 in which the dose tracker is not yet in the maximum dose
positional state 55 the indicator assembly 190 provides a first
indication 191 in the second display section 414 thus illustrating
to the user that the dose dial 12 has to be rotated further.
[0237] If the dose dial 12 has been rotated further so that the
dose tracker 50 is screwed out of the housing 10 in proximal
direction the tracking stop feature 151 engages with the
preselector stop feature 173. The position of the dose tracker 150
detected by the indicator assembly 190 then reveals that the
maximum dose positional state 55 has been reached. Accordingly, the
indicator assembly 190 is configured to provide the second
indication 192 in the second display section 414 of the display 410
thereby confirming to the user that the dose tracker 150 has
reached the intended maximum dose positional state 55. In the
configuration as shown in FIG. 21 the injection device 1 is ready
for starting a dispensing operation.
[0238] In the first display section 412 there is provided the
preselection indication 45 to which the pointer 179 of the slider
172 actually points. In the configuration of FIGS. 20 and 21 the
pointer 179 is in alignment with the smallest preselection
indication 445 of three available preselection indications 45. In
the configuration of FIGS. 22 and 23 the preselector 170 has been
displaced to a different preselection positional state 110''
compared to the preselection positional state 110 as shown in FIG.
20. Correspondingly, in the first display section 412 the
preselection indication 45 coinciding with the pointer 179 is
reproduced. In a zero dose configuration in which the dose dial 12
and hence the dose tracker 150 have not yet been dialed or
displaced in a dose incrementing direction the second display
section 414 provides the first indication 191 as described above
thereby indicating that the maximum dose positional state has not
yet been reached.
[0239] By rotating and displacing the dose tracker 50 relative to
the housing 10 along the dose incrementing direction 4 until the
maximum dose positional state 55 has been reached, as shown in FIG.
23, the electronic display 410 of the indicator assembly 190
switches to the second indication 192 thereby confirming that the
maximum dose positional state 55 has been reached. The device is
then ready to commence and to conduct a dose dispensing
procedure.
[0240] The preselector 170 comprises an extension 176. In the
present illustration the extension 176 is radially overlapping at
least with a portion of the electronic indicator assembly 190. The
extension 176 is provided with a second marker 175. The second
marker 175 is configured to interact with the sensor sections 391,
392, 393 of the second position sensor 390 as shown in FIG. 27. The
second marker 175 is provided on an outside facing surface of the
preselector 170. In any of the available preselection positional
states 110, 110', 110'' the second marker 175 is in contact or is
aligned with only one of the sensor sections 391, 392, 393. In the
preselection positional state 110 representing the smallest maximum
dose size the second marker 175 may be aligned with the sensor
section 393.
[0241] In an intermediate preselection positional state 110' the
second marker 175 is aligned with the sensor section 392. In the
preselection positional state 110'' representing a maximum dose the
second marker 175 is aligned with the sensor section 391. The
second marker 175 may be electrically conducting. Its presence or
vicinity to any one of the sensor sections 391, 392, 393 can be
electronically detected by means of the processor 420 of the
indicator assembly 190 being electrically connected to the position
sensor 390.
[0242] In a similar way the first position sensor 430 may comprise
a first detector element 422 and a second detector element 424. The
detector elements 422 424 are arranged axially offset. They may be
implemented as electrical contacts or as electromechanical
switches, which upon mechanical contact with another structure or
component may generate or interrupt an electrical signal that is
transferrable to the processor 420. On an outside surface of the
number sleeve 180 and hence on an outside surface of the dose
tracker 150 there are provided two surface sections, namely a first
surface section 182 and a second surface section 184. The surface
sections 182, 184 comprise the shape of a helical thread.
[0243] The lead of the helical threads of the first and second
surface sections 182, 184 is identical to a lead of a helical
groove 181 of the dose tracker 150 or the number sleeve 180. As the
dose tracker 150 is subject to a helical motion relative to the
sidewall 48 of the housing 10 the first detector element 422 slides
along the first surface section 182. Likewise, the second detector
element 424 slides along the second surface section 184.
[0244] In the zero dose configuration as shown in FIG. 29 both
detector elements 422, 424 are in contact with the respective first
and second surface sections 182, 184. The outside surface of the
number sleeve 180 and hence of the dose tracker 150 comprises at
least a first marker 185 by way of which the first position sensor
430 becomes enabled to determine and to detect at least one of an
axial or rotational position of the dose tracker 150. The marker
185 comprises at least two interrupts 183, 186 in the first surface
section 182 and in the second surface section 184, respectively. In
the illustration of FIGS. 29-33 the distal direction points to the
right whereas the proximal direction points to the left.
[0245] As illustrated in FIG. 31 the first surface section 182
comprises a first interrupt 183. As illustrated in FIG. 30 the
second surface section 184 comprises a second interrupt 186. After
a complete revolution of the dose tracker 150 and hence of the
number sleeve 180 the second interrupt 186 is aligned with the
second detector element 424 as illustrated in FIG. 30. In this way,
the second detector element 424 is switched. The second detector
element 424 when aligned with the interrupt 186 may generate or
interrupt an electrical signal that differs from an electrical
signal of the second detector element 424 when aligned with the
second surface section 184.
[0246] After two revolutions the opposite situation occurs as
illustrated in FIG. 31. There, the second detector element 424 is
in alignment and is in contact with the second surface section 184
while the first detector element 422 is in alignment with the first
interrupt 183 of the first surface section 182. This configuration
may represent a logical 2 while the configuration of FIG. 30 may
represent a logical 1. In FIG. 32 and after three complete
revolutions of the dose tracker 150, none of the detector elements
422, 424 remains in contact with any of the first or second surface
sections 182, 184. This configuration may represent a logical 3.
Hence, with two detector elements 424, 424 and with two surface
sections 182, 184 each of which comprising at least one
interruption 183, 186 four different discrete states of the dose
tracker 150 can be electronically detected and determined.
[0247] The detector elements 421, 422, 424 can be implemented as
mechanical switches when the surface sections 382, 384 and the
interrupts 183, 186 comprise different radial height or depth on
the outside surface of the 150. For instance, the surface sections
382, 384 each comprise a longitudinal groove on the outside surface
of the number sleeve 180. The interrupts 183, 186 may flush with
the outside surface of the number sleeve 180 or of the dose tracker
150. When implemented as mechanical switches, the detector elements
422, 424 may each comprise a radially displaceable and spring
biased pin running along the respective surface section 182, 184 as
the number sleeve 180 is subject to a rotation relative to the
housing 10. When a pin of one of the detector elements 422, 424
aligns with an interrupt 183, 186 the respective pin is depressed
against the action of the spring. Such a depression is accompanied
by a closing or opening of an electrical switch or contact inside
the detector element 422, 424.
[0248] There is further illustrated an optional detector element
421 that serves as an on-off switch for the add-on device 400. The
further detector element 421 is configured to engage with a further
surface section 188 on the outside surface of the number sleeve 80.
The surface section 188 as illustrated in FIGS. 29 and 30 comprises
a confined recess in the outside surface of the number sleeve 180
or of the dose tracker 150. The recess and hence the surface
section 188 is only slightly larger than the extent of the detector
element 421. In an initial configuration or zero-dose configuration
as for instance illustrated in FIG. 29 the detector element 421 is
in alignment with the recess at the surface section 188.
[0249] As soon as the number sleeve 180 is subject to a rotation
relative to the housing 10 the detector element 421 and the recess
188 get out of engagement. Consequently, the detector element 421
will be subject to a radially outwardly directed depression as it
starts to slide outside the recessed surface section 188 and hence
along the outside surface of the number sleeve 180. In this way the
add-on device 400 and hence the electronic components thereof, in
particular its processor 420, is switched on and the status of the
further detector elements 422, 424 can be monitored and processed.
By means of a detector element 421 implemented as on/off switch,
electric energy consumption of the add-on device 400 can be reduced
and battery lifetime can be prolonged.
[0250] When after completion of a dose dispensing procedure the
detector element 421 re-engages the recessed surface section 188
the add-on device 400 is switched off and electric energy can be
saved.
[0251] The first position sensor 430 and the second position sensor
390 can be implemented in many different ways. Here, the first and
second surface sections 182, 184 may be provided as radial grooves
while the interrupts 183, 186 protrude radially from the respective
groove. Alternatively, the interrupts 183, 186 can be provided as
non-conductive sections on respective first and second electrically
conductive surface sections 182, 184; or vice versa. Alternatively,
the first and/or second surface sections 182, 184 could be
electrically or magnetically encoded. For instance, the surface
sections 182, 184 may be electrically conductive while the
interrupts 183, 186 are electrically insulating or non-conductive.
It is also conceivable that the surface sections 182, 184 and the
interrupts 183, 186 mutually distinguish in terms of their visual
appearance or light absorption characteristic as well and/or with
regards to their magnetic properties.
[0252] In this way also other encoding schemes based on an optic
encoding or magnetic encoding can be generally implemented. With an
optically or magnetically implemented encoding of the outside
surface 85 of the dose tracker 150 or the number sleeve 180 also
respective first and second detector elements 422, 424 should be
implemented. Here, first and second detector elements 422, 424 may
be implemented as light detectors or as magnetic sensors.
[0253] In a situation wherein the slider 172 is located near the
proximal end of the displacement path and wherein a maximum dose
has been pre-selected, i.e. with the pointer 179 of the slider 172
aligns with the preselection indication 45 provided with number 3
the configurations as shown in FIGS. 29, 30 and 31 correspond to
positions of the dose tracker 150 and hence of the number sleeve
180 that are smaller than the pre-selected dose size. Only when
arriving in the proximal end position, in which the preselector
stop feature 173 engages with the tracking stop feature 151 the
electronic position detection of the dose tracker 150 coincides
with the electronic position detection of the preselector 170. In
such a situation the processor 420 is configured to switch the
indicator 415 in the second display section 414 to confirm that the
intended dose size has been set.
[0254] These electronic components may belong to the injection
device 1 and hence to the dose setting mechanism 9 thereof. The
injection device 1 may be further equipped with one or several
electric power sources 402, such as button batteries. The electric
power sources 402 can be integrated into the housing 10 or can be
detachably mounted inside the housing 10 and/or its sidewall
48.
[0255] In a further embodiment and as indicated in FIG. 26 the
electronic components as well as the electric power sources 402 can
be all integrated into an add-on device 400 that may be detachably
connectable to the housing 10, in particular to its sidewall 48. A
detachable add-on device 400 may be usable with disposable
injection devices that are equipped with a pre-filled cartridge 6
and which are intended to be discarded entirely after the content
of the cartridge 6 has been used up.
[0256] Here, the injection device 1 could be void of an own
indicator assembly 190. The add-on device 400 can be provided with
a remote indicator assembly 490 which has the same structure as the
indicator assembly 190 as described above. Here, all components
belonging to the indicator assembly 190 are provided on the
detachable add-on device 400, which may have a fastener or
fastening structure 404 to engage with a correspondingly shaped
counter fastener 406 in order to guarantee a correct and
well-defined position of the add-on device 400 relative to the
housing 10, to the dose tracker 150 and to the preselector 170.
[0257] The add-on device 400 is further equipped with the above
mentioned first and second position sensors 430, 390 configured to
detect and to determine a position of the dose tracker 150 relative
to the preselector 170.
TABLE-US-00001 List of reference numbers 1 injection device 2
distal direction 3 proximal direction 4 dose incrementing direction
5 dose decrementing direction 6 cartridge 7 bung 8 drive mechanism
9 dose setting mechanism 10 housing 11 trigger 12 dial 13 dosage
window 14 cartridge holder 15 injection needle 16 inner needle cap
17 outer needle cap 18 protective cap 20 piston rod 21 bearing 22
first thread 23 pressure foot 24 second thread 25 barrel 26 seal 28
threaded socket 30 drive sleeve 31 threaded section 32 flange 33
flange 35 last dose limiter 36 shoulder 40 spring 41 recess 42
through opening 43 bottom section 44 edge 45 preselection
indication 46 counter detent structure 47 recess 48 sidewall 49
displacement path 50 dose tracker 51 tracking stop feature 54
positional state 55 maximum dose positional state 60 clutch 62
insert 63 protrusion 64 stem 70 preselector 71 sleeve portion 72
slider 73 preselector stop feature 74 spline feature 75 aperture 76
detent structure 77 gripping structure 78 lens 79 pointer 80 number
sleeve 81 groove 82 surface section 84 surface section 85 marker 90
indicator assembly 91 indication 92 indication 110 preselection
positional state 150 dose tracker 151 tracking stop feature 170
preselector 171 sleeve portion 172 slider 173 preselector stop
feature 174 spline feature 175 marker 176 extension 177 gripping
structure 179 pointer 180 number sleeve 181 groove 182 surface
section 183 interrupt 184 surface section 185 marker 186 interrupt
188 surface section 190 indicator assembly 191 indication 192
indication 390 position sensor 391 sensor section 392 sensor
section 393 sensor section 400 add-on device 402 electric power
source 404 fastener 406 counter fastener 410 electronic display 412
display section 414 display section 420 processor 421 detector
element 422 detector element 424 detector element 430 position
sensor 440 communication unit 450 actuation element 490 remote
indicator assembly 500 external electronic device
* * * * *